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Trial Title: Contributions to Hypertension With Androgen Deprivation Therapy

NCT ID: NCT05700903

Condition: Androgen Deprivation Therapy
Prostate Cancer
Hypertension
Autonomic Dysfunction
Renal Disease

Conditions: Official terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Hypertension
Leuprolide
Goserelin
Flutamide
Bicalutamide
Hormones
Androgens

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Gonadotropin Releasing Hormone Agonists (GNRH)
Description: 8 weeks of GnRH agonist
Arm group label: Healthy + ADT
Arm group label: Prostate Cancer

Other name: Leuprolide

Other name: Goserelin

Intervention type: Drug
Intervention name: Androgen receptor (AR) inhibitor
Description: 2 weeks of AR Inhibitor
Arm group label: Healthy + ADT
Arm group label: Prostate Cancer

Other name: Bicalutamide

Other name: Flutamide

Other name: Enzalutamide

Intervention type: Drug
Intervention name: Placebo
Description: Placebo tablet and injection
Arm group label: Healthy + Placebo

Summary: This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - -age 40+ years; - resting blood pressure <140/90 mmHg; - fasted blood glucose <126 mg/dL; - testosterone ≥400 ng/dL; - sedentary to recreationally active; - nonsmokers; - healthy as determined by medical history, physical exam, blood and urine chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen deprivation therapy; - PSA <4.00 ng/dL if in the non-cancer group; - Gleason Score ≤7 if in the prostate cancer group; - no use of medications that might influence cardiovascular function (e.g., antihypertensives, lipid-lowering medications); - willing and able to be on GnRHagonist and AR inhibitor; - not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop use for four weeks prior to the start of the study; - not using exogenous sex hormones for at least one year Exclusion Criteria: - -acute liver disease; - chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g of proteinuria - pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder; - diabetes, active or chronic infection, disease that affects the nervous system; - Gleason Score ≥8; - thyroid dysfunction, defined as ultrasensitive TSH <0.5 or >5.0 mU/L, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; - tobacco use within the previous 12 months

Gender: Male

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: UCHealth University of Colorado Hospital

Address:
City: Aurora
Zip: 80045
Country: United States

Status: Recruiting

Contact:
Last name: Matthew Babcock, PhD

Phone: 720-848-6470
Email: matthew.babcock@cuanschutz.edu

Investigator:
Last name: Matthew Babcock, PhD
Email: Principal Investigator

Start date: September 20, 2023

Completion date: March 31, 2028

Lead sponsor:
Agency: University of Colorado, Denver
Agency class: Other

Source: University of Colorado, Denver

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05700903

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